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Data Privacy in the EU: A Guide for Clinical Trial Sponsors and Sites

Product Details

Note: This publication will be available in PDF format by June 19, 2020.

U.S.-based companies routinely collect and process personal data of EU-based individuals as part of their operations.

Without a working knowledge of EU privacy laws and regulations, you run the risk of not being compliant.

The broad requirements of the EU’s General Data Protection Regulation (GDPR), which applies to all industries, must be reconciled with the specific provisions of the EU’s Clinical Trial Regulation (CTR).

Data Privacy in the EU: A Guide for Clinical Trial Sponsors and Sites explains how GDPR and CTR overlap and how they compare to U.S. regulations, what data protection principles trials must follow to ensure compliance, and what requirements the EU rules place on the collection and processing of personal health information (PHI). The report also covers the rights of EU? citizens under GDPR, the need for a data protection officer (DPO) and what the DPO does, and how to conduct a privacy impact assessment.

Report Takeaways:

The difference in the way the EU and the U.S. regulate privacy

Introduction, historical and legal context of the GDPR

Application of the GDPR to clinical trials data

Data protection principles that must be followed

Transparency requirements under the GDPR vs. the CTR

The roles of sponsors, sites and CROs in handling personal data

The responsibilities of the data protection officer

Nine principles of data protection

Requirements of consent under the GDPR

Reporting data breaches

If your clinical trials involve the personal data of EU-based individuals, you need to understand the rules that apply to data collection. Order your copy today.